Clinical Observation On Duanteng Yimu Decoction Combined With Leflunomide In Treating Rheumatoid Arthritis

ObjectiveTo evaluate the efficacy and safety of duanteng yimu decoction combined with leflunomide in active rheumatoid arthritis(RA).MethodsA randomized controlled trial in60patients according with the standard of RA was conducted. Patients were divided into therapy group (n=30) and control group(n=30). Both group were treated by duanteng yimu decoction, a dose one day, and the therapy group was also treated with leflunomide,20mg, qd, for12weeks. Clinical assessments including28-joint count for tenderness and swelling, morning stiffness, pain VAS(Visual Analogue Scale/Score), health assessment questionnaire(HAQ), and the global assessments about disease activity of patiengts and physicians were observed at baseline,2,6and12weeks after treatment. Laboratory indexes including ESR, RF, CRP and anti-CCP were observed at baseline and12weeks after treatment. The function of liver and kidney,blood and urine routine were monitored, and the adverse reactions of the drugs were recorded. Efficacy was mainly assessed using the American College of Rheumatology criteria for20%improvement(ACR20).ResultsAfter12weeks treatment, ACR20in the therapy group and the control group was86.21%and56.67%, respectively, and there was significant difference between the two group(p<0.05), however, ACR50in the therapy group and the control group was34.48%and23.33%(p>0.05). Compared to original level, the DAS28was improved significantly in both groups (p<0.05), and the total effective rate of DAS28in the therapy group was75.86%, more significantly higher than56.67%of the control group(p<0.05). After2weeks treatment, compared to the original level,28-joint count for tenderness, pain VAS, HAQ, and the global assessments about disease activity of patiengts and physicians were improved significantly in both groups (p<0.05). After6and12weeks treatment, compared to the original level, all the clinical assessments were improved significantly in both groups(p<0.01).There was no significant difference between both groups after2weeks treatment on every aspect of all clinical assessments(p>0.05). But after6weeks treatment,28-joint count for tenderness and pain VAS in the therapy group were improved more significantly than those in the control group. After finishing the trial, there was difference in28-joint count for tenderness and swelling, morning stiffness, pain VAS, HAQ, and the global assessments about disease activity of patiengts and physicians between them(p<0.05), pointing out that the therapy group was better than the other one.After the treatment, ESR, RF, CRP and anti-CCP in both groups had significant improvement, statistically significant difference(p<0.05), and CRP and anti-CCP of the therapy group were improved significantly than the control group,(p<0.05).The incidence of adverse reactions was41.37%and36.67%in the therapy group and the control group, respectively, and there was no significant difference between them(p>0.05). During the12weeks treatment,in the therapy group, ALT and AST elevation was reported in3patients, WBC descent2patients, infection of the upper respiratory tract1patient, gastrointestinal reactions3patients, and irregular menstruation3patients, and there were1,1,2,3and4patients respectively in the control group. There was no sever adverse action in the progress of the treatment, showing that both were safe. ConclusionsBoth groups are effective and safe in RA, and the efficacy of therapy group is better than that of control group, but duanteng yimu decoction acts earlily.